Form 483 · FEI 3004555163
Form 483 issued May 27, 2022 · Jiutepec, Mexico
- Inspection
- May 23 – May 27, 2022
- Investigators
- Nicole E. Knowlton· Rafeeq Habeeb
- Observations
- 10
- Pages
- 7
- FEI number
- 3004555163
In short: On May 27, 2022, FDA issued a Form 483 with 10 observations to an FDA-inspected site in Jiutepec, Morelos (FEI 3004555163) after an inspection that ran May 23 – May 27, 2022. The investigators were Nicole E. Knowlton and Rafeeq Habeeb. Most observations concern laboratory controls and facilities & equipment; the most-cited regulation is 21 CFR 211.194 (laboratory records).
At a glance
Laboratory controls and facilities & equipment account for 7 of 10 observations.
What FDA observed
Preview: the opening words of each observation- 01
Representative samples are not taken of each shipment of each lot of components…
- 02
Laboratory records do not include complete data derived from all tests, examinations and assay necessary to…
- 03
Appropriate controls are not exercised over computers or related systems to assure that changes in taster…
- 04
The written stability program for drug products does not include test intervals based on statistical criteria…
This inspection in context
Nicole E. Knowlton
36 documents · 2013–2026
Cites 211.68 (automatic, mechanical, and electronic equipment) more than any other section. Most of their documents are for sites in Florida.
The firmSite history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.84(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at an FDA-inspected site?
FDA listed 10 observations on this Form 483, mostly about laboratory controls, facilities & equipment and materials. The most-cited regulation is 21 CFR 211.194 (laboratory records). The opening words of each observation are shown on this page.
Who inspected an FDA-inspected site?
Nicole E. Knowlton and Rafeeq Habeeb are named on this Form 483, for the inspection of May 23 – May 27, 2022. Each investigator has a profile showing what they cite most.
When was an FDA-inspected site inspected by FDA?
The inspection ran May 23 – May 27, 2022, and the Form 483 is dated May 27, 2022.
How do I get the full Form 483 for an FDA-inspected site?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.