Hieber's Pharmacy
Form 483 issued September 18, 2014 · Pittsburgh, Pennsylvania
- Inspection
- Sep 8 – Sep 18, 2014
- Investigators
- Cynthia L. Rakestraw· Thomas E. Friel
- Observations
- 5
- Pages
- 2
- FEI number
- 1000121499
In short: On September 18, 2014, FDA issued a Form 483 with 5 observations to Hieber's Pharmacy in Pittsburgh, Pennsylvania (FEI 1000121499) after an inspection that ran Sep 8 – Sep 18, 2014. The investigators were Cynthia L. Rakestraw and Thomas E. Friel. Most observations concern laboratory controls and production; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
3 of 5 observations on this 483 concern laboratory controls.
Most cited: 21 CFR 211.113(b) (2×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be…
- 03
Each batch of drug product purporting to be sterile and pyrogen-free is not laboratory tested to…
- 04
An adequate number of batches of each drug product are not tested to determine…
This inspection in context
Cynthia L. Rakestraw
2 documents · 2014
Cites 211.113(b) (control of microbiological contamination) more than any other section. Most of their documents are for sites in Pennsylvania.
The firmHieber's Pharmacy history
All 7 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.113(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Hieber's Pharmacy?
FDA listed 5 observations on this Form 483, mostly about laboratory controls and production. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Hieber's Pharmacy?
Cynthia L. Rakestraw and Thomas E. Friel are named on this Form 483, for the inspection of Sep 8 – Sep 18, 2014. Each investigator has a profile showing what they cite most.
When was Hieber's Pharmacy inspected by FDA?
The inspection ran Sep 8 – Sep 18, 2014, and the Form 483 is dated September 18, 2014.
How do I get the full Form 483 for Hieber's Pharmacy?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.