Pine Pharmacy and Home Care Products Center, Inc.
FDA inspection history across 2 sites, 2013 to 2019
- 3
- Form 483s
- 1
- Close-out
- 1
- Response
- 1
- Warning letter
Every document, by year
- Close-out
- Response
- Form 483
- Warning letter
2013: two Form 483s; 2015: one warning letter; 2016: one 483 response and one Form 483; 2019: one close-out letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2013–16Three Form 483s, one warning letter and one 483 response, at Williamsvil le, New York and Williamsville, New York.
- 2013The longest 483 on file: 10 observations over 5 pages at Williamsvil le, New York.
- 2019One close-out letter, at Williamsville, New York.
Cited most
Across all Pine Pharmacy and Home Care Products Center observations on file
- 21 CFR 211.113Control of microbiological contamination4
- 21 CFR 211.166Stability testing4
- 21 CFR 211.42Design and construction features4
- 21 CFR 211.28Personnel responsibilities3
- 21 CFR 211.160(b)General requirements2
The complete Pine Pharmacy and Home Care Products Center file.
All 6 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
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Sites
Williamsville, New York
One close-out letter, one 483 response and one warning letter · 2015 to 2019
Latest: Close-out, Apr 25, 2019 →Williamsvil le, New York
Three Form 483s · 2013 to 2016 · 27 observations
Latest: Form 483, Apr 18, 2016 →
Documents
6 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2019-04-25 | Close-out Close-out letter | Williamsville, New York | — | $99 |
| 2016-11-07 | Response 483 response | Williamsville, New York | — | $199 |
| 2016-04-18 | 483 Form 483 | Williamsvil le, New York | 8 | $99 |
| 2015-02-13 | Warning letter Warning letter | Williamsville, New York | — | $99 |
| 2013-12-16 | 483 Form 483 | Williamsvil le, New York | 9 | $99 |
| 2013-07-19 | 483 Form 483 | Williamsvil le, New York | 10 | $99 |
Investigators on these documents
FEI number 3010285019 · most recent document Apr 25, 2019
About Pine Pharmacy and Home Care Products Center, Inc.
How many FDA Form 483s has Pine Pharmacy and Home Care Products Center, Inc. received?
FDA Intel has 3 Form 483s on file for Pine Pharmacy and Home Care Products Center, Inc.; the most recent is dated Apr 18, 2016.
When was Pine Pharmacy and Home Care Products Center, Inc. last inspected by FDA?
The most recent FDA inspection document on file for Pine Pharmacy and Home Care Products Center, Inc. is a Form 483 dated Apr 18, 2016, for the site in Williamsvil le, New York.
What did FDA cite at Pine Pharmacy and Home Care Products Center, Inc.?
The regulations cited most in the observations on file for Pine Pharmacy and Home Care Products Center, Inc. are 21 CFR 211.113 (Control of microbiological contamination), 4 times; 21 CFR 211.166 (Stability testing), 4 times; 21 CFR 211.42 (Design and construction features), 4 times.
Has Pine Pharmacy and Home Care Products Center, Inc. received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Pine Pharmacy and Home Care Products Center, Inc.; the most recent is dated Feb 13, 2015.