Advanced Pharma, Inc.
FDA inspection history across 2 sites, 2014 to 2018
- 2
- Form 483s
- 1
- Warning letter
Every document, by year
- Warning letter
- Form 483
2014: one Form 483; 2016: one Form 483; 2018: one warning letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2014–18Two Form 483s and one warning letter, at Houston, Texas and Texas.
- 2014The longest 483 on file: 6 observations over 3 pages at Houston, Texas.
Cited most
Across all Advanced Pharma observations on file
- 21 CFR 211.113Control of microbiological contamination2
- 21 CFR 211.160General requirements2
- 21 CFR 211.167Special testing requirements2
- 21 CFR 211.165Testing and release for distribution1
- 21 CFR 211.42Design and construction features1
The complete Advanced Pharma 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
Houston, Texas
Two Form 483s · 2014 to 2016 · 11 observations
Latest: Form 483, Jul 22, 2016 →Texas
One warning letter · 2018
Latest: Warning letter, Aug 14, 2018 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2018-08-14 | Warning letter Warning letter | Texas | — | $99 |
| 2016-07-22 | 483 Form 483 | Houston, Texas | 5 | $99 |
| 2014-03-17 | 483 Form 483 | Houston, Texas | 6 | $99 |
Investigators on these documents
FEI number 3005247494 · most recent document Aug 14, 2018
About Advanced Pharma, Inc.
How many FDA Form 483s has Advanced Pharma, Inc. received?
FDA Intel has 2 Form 483s on file for Advanced Pharma, Inc.; the most recent is dated Jul 22, 2016.
When was Advanced Pharma, Inc. last inspected by FDA?
The most recent FDA inspection document on file for Advanced Pharma, Inc. is a Form 483 dated Jul 22, 2016, for the site in Houston, Texas.
What did FDA cite at Advanced Pharma, Inc.?
The regulations cited most in the observations on file for Advanced Pharma, Inc. are 21 CFR 211.113 (Control of microbiological contamination), 2 times; 21 CFR 211.160 (General requirements), 2 times; 21 CFR 211.167 (Special testing requirements), 2 times.
Has Advanced Pharma, Inc. received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Advanced Pharma, Inc.; the most recent is dated Aug 14, 2018.