Drug establishmentActive, Registered FY2026FDA warning letter on file

Medical Products Laboratories, Inc.

Medical Products Laboratories, Inc. is an FDA-registered drug establishment (FEI 2513595) located in Philadelphia, Pennsylvania. The facility is active, registered for FY2026. Its most recent FDA inspection on record (2023-07-13) was classified VAI. FDA has issued 1 warning letter(s) to this facility.

FDA warning letter

Apr 9, 2026
CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug

A warning letter is FDA's formal notice of significant violations that require prompt correction. It can hold up product approvals, trigger import alerts, and put supply agreements at risk until the issues are resolved and FDA closes it out.

Establishment record

FEI Number
2513595
Address
9990 Global Road, Philadelphia, Pennsylvania
Establishment type
Drug establishment
Products / operations
Analytical testing, Labeling, Manufacturing, Packaging, Relabeling, Repackaging
Registration status
Active, Registered FY2026

Verify this record on FDA.gov ›

Inspection history

Inspections on file
Jul 13, 2023 · Voluntary Action Indicated (VAI)
Jul 13, 2023 · Voluntary Action Indicated (VAI)
Mar 13, 2020 · Voluntary Action Indicated (VAI)
Mar 13, 2020 · Voluntary Action Indicated (VAI)
Oct 12, 2017 · No Action Indicated (NAI)
Oct 12, 2017 · Voluntary Action Indicated (VAI)
Jul 21, 2015 · Voluntary Action Indicated (VAI)
Jul 21, 2015 · Voluntary Action Indicated (VAI)
Feb 24, 2014 · Voluntary Action Indicated (VAI)
Feb 24, 2014 · Voluntary Action Indicated (VAI)
Feb 24, 2014 · Voluntary Action Indicated (VAI)
Feb 24, 2014 · Voluntary Action Indicated (VAI)
Form 483 observations
Jul 13, 2023, 1 observation: Equipment Design, Size and Location
Jul 21, 2015, 3 observations: SOPs not followed / documented; Scientifically sound laboratory controls; Quarantine of Rejected Components et. al.
Feb 24, 2014, 14 observations: Investigations of discrepancies, failures; Buildings not maintained in good state of repair; Storage under appropriate conditions
Apr 27, 2011, 1 observation: Buildings not maintained in good state of repair
Jun 14, 2010, 14 observations: Absence of Written Procedures; Containers sampled so as to prevent contamination; Management review - Lack of or inadequate procedures

Questions

Is Medical Products Laboratories, Inc. registered with the FDA?

Yes. Medical Products Laboratories, Inc. is an FDA-registered drug establishment (FEI 2513595) in Philadelphia, Pennsylvania. Its current registration status is Active, Registered FY2026.

Has Medical Products Laboratories, Inc. received an FDA warning letter?

Yes. FDA issued a warning letter to Medical Products Laboratories, Inc.; the most recent is dated Apr 9, 2026 (CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug).

What does Medical Products Laboratories, Inc. do?

Medical Products Laboratories, Inc.'s FDA-registered operations are: Analytical testing, Labeling, Manufacturing, Packaging, Relabeling, Repackaging.

Related facilities

Source: FDA public data · status as of 2026-06-06

The Quality Brief

Every new FDA drug and device warning letter and recall, summarized once a week. Free.