Every FDA investigator brings a unique style and focus to inspections. Jose O. Hernandez is no exception. With more than 70 FDA inspections, over 50 Form 483s, and 3 Warning Letters issued, Hernandez has built a reputation for his meticulous approach, especially when it comes to sterile manufacturing and environmental controls.
In this article, we break down 10 notable Jose Hernandez FDA inspections, highlight common themes in his findings, and share what pharmaceutical and biotech compliance teams can learn to stay inspection‑ready.
Here’s the thing: not all FDA inspectors scrutinize the same risks the same way. Even though all operate under the same regulations, they each bring personal experience and professional focus to the job.
Some lean heavily on quality system audits. Others zero in on data integrity or supply chain oversight. Hernandez consistently shines a light on aseptic discipline and sterility assurance, areas where process weaknesses tend to hide.
Understanding Jose Hernandez's FDA inspection history gives these advantages:
Here’s what we know from public records:
Let’s look at 10 representative inspections to understand his approach in practice.
Each inspection below illustrates not just what Hernandez found, but what the FDA expects and how you can apply the lesson at your own facility.
Hernandez cited inadequate gowning and improper glove changes in the cleanroom. Observations also noted incomplete batch records and improperly cleaned equipment.
Lesson: Your gowning SOPs are only as good as how consistently they’re followed and documented.
Equipment calibration and maintenance gaps were called out, along with poor environmental monitoring records.
Lesson: Don’t let calibration dates slip—an out‑of‑tolerance reading can invalidate batches.
Findings focused on environmental monitoring failures—HEPA filters not tested on schedule, no corrective actions after detecting particles beyond alert levels.
Lesson: Continuous monitoring and documented responses matter as much as the initial test results.
Observed maintenance and cleaning documentation lapses, including the reuse of cleaning materials in sterile areas.
Lesson: Maintenance and cleaning logs must be detailed and up to date—shortcuts in documentation can imply shortcuts in practice.
Product storage at improper temperatures and a lack of proper controls for controlled substances were flagged.
Lesson: Environmental controls extend beyond the cleanroom—warehousing needs attention, too.
International inspection highlighted incomplete validation records for new equipment and a lack of personnel requalification.
Lesson: Personnel training and requalification records are as critical overseas as at home.
The focus was on inadequate sterility testing methods and insufficient controls during filling operations.
Lesson: Sterility assurance starts with sound sampling plans and validated test methods.
Airflow patterns during aseptic operations were disrupted by improper operator positioning, and gowning violations were noted.
Lesson: Train operators to understand how their movements impact airflow integrity.
Multiple SOP deviations went undocumented, and QA oversight was found to be inadequate.
Lesson: Quality oversight should actively catch and document all deviations, no matter how small.
One of his inspections escalated to a Warning Letter after repeat violations were found in sterile manufacturing areas, including a lack of effective CAPAs.
Lesson: A Form 483 is a warning. Ignoring or inadequately addressing it risks public escalation.
Looking at these inspections in aggregate, three recurring weaknesses emerge. If you fix these at your facility, you’ll significantly lower your risk of citation from Hernandez or any other investigator with a similar focus.
Hernandez repeatedly documents gowning violations: improper donning techniques, contaminated gloves entering sterile areas, or compromised garments.
Out-of-tolerance equipment, unvalidated repairs, or missing maintenance logs come up time and again.
Hernandez clearly expects more than just numbers on a chart; he looks for evidence of continuous control, trend analysis, and follow-up on excursions.
The patterns you see in Hernandez’s inspections aren’t unique to him — they mirror the FDA’s ongoing priorities:
The FDA isn’t expecting perfection; they’re looking for proof that you understand your risks, control them effectively, and improve over time.
Jose Hernandez’s inspection history sends a clear message: the FDA remains sharply focused on aseptic operations, equipment readiness, and environmental control. Facilities that master these basics not only avoid Form 483s but also protect product quality and patient safety.
Understanding an investigator’s history helps you align with what the FDA considers critical. Platforms like Atlas Compliance make it easier to see trends, prepare your team, and stay ahead of risks.
