Agropharma Laboratories Inc
FDA inspection history in Salinas, Puerto Rico, 2000 to 2022
- 2
- Warning letters
- 1
- Form 483
Every document, by year
- Warning letter
- Form 483
2000: one warning letter; 2016: one Form 483; 2022: one warning letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2000One warning letter, at Salinas, Puerto Rico.
- 2016One Form 483, at Salinas, Puerto Rico.
- 2022One warning letter, at Salinas, Puerto Rico.
Cited most
Across all Agropharma Laboratories observations on file
- 21 CFR 211.22(a)Responsibilities of quality control unit2
- 21 CFR 111.110(b)What quality control operations are required for laboratory operations associated with the production and process control system?1
- 21 CFR 111.260(l)(1)(i)What must the batch record include?1
- 21 CFR 111.315(b)What are the requirements for laboratory control processes?1
- 21 CFR 211.100(a)Written procedures; deviations1
The complete Agropharma Laboratories file.
All 3 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Salinas, Puerto Rico
Two warning letters and one Form 483 · 2000 to 2022 · 13 observations
Latest: Warning letter, Mar 25, 2022 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2022-03-25 | Warning letter Warning letter | Salinas, Puerto Rico | — | $99 |
| 2016-02-12 | 483 Form 483 | Salinas, Puerto Rico | 13 | $99 |
| 2000-05-30 | Warning letter Warning letter | Salinas, Puerto Rico | — | $99 |
Investigators on these documents
FEI number 3000203462 · most recent document Mar 25, 2022
About Agropharma Laboratories Inc
How many FDA Form 483s has Agropharma Laboratories Inc received?
FDA Intel has 1 Form 483 on file for Agropharma Laboratories Inc; the most recent is dated Feb 12, 2016.
When was Agropharma Laboratories Inc last inspected by FDA?
The most recent FDA inspection document on file for Agropharma Laboratories Inc is a Form 483 dated Feb 12, 2016, for the site in Salinas, Puerto Rico.
What did FDA cite at Agropharma Laboratories Inc?
The regulations cited most in the observations on file for Agropharma Laboratories Inc are 21 CFR 211.22(a) (Responsibilities of quality control unit), 2 times; 21 CFR 111.110(b) (What quality control operations are required for laboratory operations associated with the production and process control system?), 1 time; 21 CFR 111.260(l)(1)(i) (What must the batch record include?), 1 time.
Has Agropharma Laboratories Inc received an FDA warning letter?
Yes. FDA Intel has 2 FDA warning letters on file for Agropharma Laboratories Inc; the most recent is dated Mar 25, 2022.