Medical Products Laboratories, Inc
Form 483 issued March 13, 2020 · Philadelphia, Pennsylvania
- Inspection
- Feb 24 – Mar 13, 2020
- Investigators
- Christina K. Theodorou· Rachael O. Oyewole
- Observations
- 5
- Pages
- 7
- FEI number
- 2513595
In short: On March 13, 2020, FDA issued a Form 483 with 5 observations to Medical Products Laboratories, Inc in Philadelphia, Pennsylvania (FEI 2513595) after an inspection that ran Feb 24 – Mar 13, 2020. The investigators were Christina K. Theodorou and Rachael O. Oyewole. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
Quality system and facilities & equipment account for 3 of 5 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The responsibilities and procedures applicable to the quality control unit are not in…
- 02
Written records of investigations into unexplained discrepancies do not always include…
- 03
Procedures for the cleaning and maintenance of equipment are deficient regarding sufficient detail of the methods…
- 04
Deviations from written production and process control procedures are…
This inspection in context
Christina K. Theodorou
19 documents · 2016–2026
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in Pennsylvania.
The firmMedical Products Laboratories, Inc history
All 5 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.22
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Medical Products Laboratories, Inc?
FDA listed 5 observations on this Form 483, mostly about quality system, facilities & equipment and production. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
Who inspected Medical Products Laboratories, Inc?
Christina K. Theodorou and Rachael O. Oyewole are named on this Form 483, for the inspection of Feb 24 – Mar 13, 2020. Each investigator has a profile showing what they cite most.
When was Medical Products Laboratories, Inc inspected by FDA?
The inspection ran Feb 24 – Mar 13, 2020, and the Form 483 is dated March 13, 2020.
How do I get the full Form 483 for Medical Products Laboratories, Inc?
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.