Hieber's Pharmacy
FDA inspection history in Pittsburgh, Pennsylvania, 2014 to 2020
- 3
- Form 483s
- 2
- Warning letters
- 1
- Close-out
- 1
- Response
Every document, by year
- Close-out
- Form 483
- Warning letter
- Response
2014: one 483 response and one Form 483; 2015: one warning letter; 2017: one warning letter and one Form 483; 2019: one Form 483; 2020: one close-out letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2014–20Three Form 483s, two warning letters, one 483 response and one close-out letter, at Pittsburgh, Pennsylvania.
- 2017The longest 483 on file: 8 observations over 5 pages at Pittsburgh, Pennsylvania.
Cited most
Across all Hieber's Pharmacy observations on file
- 21 CFR 211.113Control of microbiological contamination4
- 21 CFR 211.165(a)Testing and release for distribution2
- 21 CFR 211.166Stability testing2
- 21 CFR 211.167(a)Special testing requirements2
- 21 CFR 211.28(a)Personnel responsibilities1
The complete Hieber's Pharmacy file.
All 7 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
15% off buying them one by one
Sites
Pittsburgh, Pennsylvania
Three Form 483s, two warning letters, one close-out letter and one 483 response · 2014 to 2020 · 14 observations
Latest: Close-out, May 1, 2020 →
Documents
7 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2020-05-01 | Close-out Close-out letter | Pittsburgh, Pennsylvania | — | $99 |
| 2019-07-17 | 483 Form 483 | Pittsburgh, Pennsylvania | 1 | $99 |
| 2017-12-05 | Warning letter Warning letter | Pittsburgh, Pennsylvania | — | $99 |
| 2017-02-17 | 483 Form 483 | Pittsburgh, Pennsylvania | 8 | $99 |
| 2015-09-29 | Warning letter Warning letter | Pittsburgh, Pennsylvania | — | $99 |
| 2014-10-07 | Response 483 response | Pittsburgh, Pennsylvania | — | $199 |
| 2014-09-18 | 483 Form 483 | Pittsburgh, Pennsylvania | 5 | $99 |
Investigators on these documents
Cynthia L. Rakestraw (2)Thomas E. Friel (2)Gayle S. Lawson (1)Lisa B. Orr (1)Lisa Orrs (1)
FEI number 1000121499 · most recent document May 1, 2020
About Hieber's Pharmacy
How many FDA Form 483s has Hieber's Pharmacy received?
FDA Intel has 3 Form 483s on file for Hieber's Pharmacy; the most recent is dated Jul 17, 2019.
When was Hieber's Pharmacy last inspected by FDA?
The most recent FDA inspection document on file for Hieber's Pharmacy is a Form 483 dated Jul 17, 2019, for the site in Pittsburgh, Pennsylvania.
What did FDA cite at Hieber's Pharmacy?
The regulations cited most in the observations on file for Hieber's Pharmacy are 21 CFR 211.113 (Control of microbiological contamination), 4 times; 21 CFR 211.165(a) (Testing and release for distribution), 2 times; 21 CFR 211.166 (Stability testing), 2 times.
Has Hieber's Pharmacy received an FDA warning letter?
Yes. FDA Intel has 2 FDA warning letters on file for Hieber's Pharmacy; the most recent is dated Dec 5, 2017.