Pharmco Laboratories Inc.
FDA inspection history in Titusville, Florida, 2015 to 2025
- 4
- Form 483s
- 1
- Warning letter
Every document, by year
- Form 483
- Warning letter
2015: one Form 483; 2016: one warning letter; 2021: one Form 483; 2025: one Form 483 and one amended 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2015–16One Form 483 and one warning letter, at Titusville, Florida.
- 2015The longest 483 on file: 20 observations over 10 pages at Titusville, Florida.
- 2021One Form 483, at Titusville, Florida.
- 2025One Form 483 and one amended 483, at Titusville, Florida.
Cited most
Across all Pharmco Laboratories observations on file
- 21 CFR 211.160General requirements5
- 21 CFR 211.192Production record review5
- 21 CFR 211.22Responsibilities of quality control unit4
- 21 CFR 211.170Reserve samples3
- 21 CFR 211.63Equipment design, size, and location3
The complete Pharmco Laboratories file.
All 5 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
15% off buying them one by one
Sites
Titusville, Florida
Three Form 483s, one amended 483 and one warning letter · 2015 to 2025 · 42 observations
Latest: Form 483, Mar 20, 2025 →
Documents
5 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2025-03-20 | 483 Form 483 | Titusville, Florida | 6 | $99 |
| 2025-03-20 | Amended 483 Amended 483 | Titusville, Florida | 6 | $99 |
| 2021-09-22 | 483 Form 483 | Titusville, Florida | 10 | $99 |
| 2016-12-15 | Warning letter Warning letter | Titusville, Florida | — | $99 |
| 2015-11-30 | 483 Form 483 | Titusville, Florida | 20 | $99 |
Investigators on these documents
Damaris Y. Hernandez (2)Michael Z. Weigman (2)Ileana Barreto-Pettit (1)Nicole E. Knowlton (1)
FEI number 1048788 · most recent document Mar 20, 2025
About Pharmco Laboratories Inc.
How many FDA Form 483s has Pharmco Laboratories Inc. received?
FDA Intel has 4 Form 483s on file for Pharmco Laboratories Inc.; the most recent is dated Mar 20, 2025.
When was Pharmco Laboratories Inc. last inspected by FDA?
The most recent FDA inspection document on file for Pharmco Laboratories Inc. is a Form 483 dated Mar 20, 2025, for the site in Titusville, Florida.
What did FDA cite at Pharmco Laboratories Inc.?
The regulations cited most in the observations on file for Pharmco Laboratories Inc. are 21 CFR 211.160 (General requirements), 5 times; 21 CFR 211.192 (Production record review), 5 times; 21 CFR 211.22 (Responsibilities of quality control unit), 4 times.
Has Pharmco Laboratories Inc. received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Pharmco Laboratories Inc.; the most recent is dated Dec 15, 2016.