Advance Pharmaceutical In a
FDA inspection history in Holtsville, New York, 2015
- 2
- Form 483s
Every document, by year
- Form 483
2015: two Form 483s.
The story so far
Built from the dates and citations on the documents themselves.
- 2015Two Form 483s, at Holtsville, New York.
- 2015The longest 483 on file: 11 observations over 7 pages at Holtsville, New York.
Cited most
Across all Advance Pharmaceutical In a observations on file
- 21 CFR 211.100(a)Written procedures; deviations3
- 21 CFR 211.110(a)Sampling and testing of in-process materials and drug products2
- 21 CFR 211.192Production record review2
- 21 CFR 211.166(a)Stability testing1
- 21 CFR 211.170(b)Reserve samples1
The complete Advance Pharmaceutical In a file.
All 2 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
Holtsville, New York
Two Form 483s · 2015 · 16 observations
Latest: Form 483, Dec 2, 2015 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2015-12-02 | 483 Form 483 | Holtsville, New York | 11 | $99 |
| 2015-03-06 | 483 Form 483 | Holtsville, New York | 5 | $99 |
Investigators on these documents
Clarisse K. Green (1)Demitria J. Xiradakis (1)Robert A. Mier (1)Samina S. Khan (1)
FEI number 2434807 · most recent document Dec 2, 2015
About Advance Pharmaceutical In a
How many FDA Form 483s has Advance Pharmaceutical In a received?
FDA Intel has 2 Form 483s on file for Advance Pharmaceutical In a; the most recent is dated Dec 2, 2015.
When was Advance Pharmaceutical In a last inspected by FDA?
The most recent FDA inspection document on file for Advance Pharmaceutical In a is a Form 483 dated Dec 2, 2015, for the site in Holtsville, New York.
What did FDA cite at Advance Pharmaceutical In a?
The regulations cited most in the observations on file for Advance Pharmaceutical In a are 21 CFR 211.100(a) (Written procedures; deviations), 3 times; 21 CFR 211.110(a) (Sampling and testing of in-process materials and drug products), 2 times; 21 CFR 211.192 (Production record review), 2 times.