Hieber's Pharmacy
Form 483 issued February 17, 2017 · Pittsburgh, Pennsylvania
- Inspection
- Feb 6 – Feb 10, 2017
- Investigators
- Gayle S. Lawson· Lisa B. Orr
- Observations
- 8
- Pages
- 5
- FEI number
- 1000121499
In short: On February 17, 2017, FDA issued a Form 483 with 8 observations to Hieber's Pharmacy in Pittsburgh, Pennsylvania (FEI 1000121499) after an inspection that ran Feb 6 – Feb 10, 2017. The investigators were Gayle S. Lawson and Lisa B. Orr. Most observations concern production and laboratory controls; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Production and laboratory controls account for 6 of 8 observations.
Most cited: 21 CFR 211.113 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Observation 1: scanned text, readable in the full document.
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be…
- 03
Observation 3: scanned text, readable in the full document.
- 04
Each batch of drug product purporting to be sterile and pyrogen-free is not laboratory tested to…
This inspection in context
Gayle S. Lawson
10 documents · 2015–2019
Cites 211.22 (responsibilities of quality control unit) 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
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Hieber's Pharmacy?
FDA listed 8 observations on this Form 483, mostly about production, laboratory controls and facilities & equipment. 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?
Gayle S. Lawson and Lisa B. Orr are named on this Form 483, for the inspection of Feb 6 – Feb 10, 2017. Each investigator has a profile showing what they cite most.
When was Hieber's Pharmacy inspected by FDA?
The inspection ran Feb 6 – Feb 10, 2017, and the Form 483 is dated February 17, 2017.
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.