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

Read the letter on FDA.gov ›

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 in FDA source data ›

Inspection history

Inspections on file

Jul 13, 2023 · Voluntary Action Indicated (VAI)
Mar 13, 2020 · Voluntary Action Indicated (VAI)
Oct 12, 2017 · Voluntary Action Indicated (VAI)
Oct 12, 2017 · No Action Indicated (NAI)
Jul 21, 2015 · Voluntary Action Indicated (VAI)
Feb 24, 2014 · Voluntary Action Indicated (VAI)
Jul 13, 2011 · No Action Indicated (NAI)
Apr 27, 2011 · Voluntary Action Indicated (VAI)
Jun 14, 2010 · 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: Quarantine of Rejected Components et. al.; Procedures for non-sterile drug products; Cleaning / Sanitizing / Maintenance
Apr 27, 2011, 1 observation: Buildings not maintained in good state of repair
Jun 14, 2010, 14 observations: Documentation - review in response to changes or deviations; Lack of or inadequate organizational structure; Adequate number of batches on stability

FDA record timeline

Apr 9, 2026

Warning letter

CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug

Source ›

Jul 13, 2023

FDA inspection

VAI classification

Jul 13, 2023

Form 483

1 observation

Mar 13, 2020

FDA inspection

VAI classification

Oct 12, 2017

FDA inspection

VAI classification

Oct 12, 2017

FDA inspection

NAI classification

Jul 21, 2015

FDA inspection

VAI classification

Jul 21, 2015

Form 483

3 observations

Feb 24, 2014

FDA inspection

VAI classification

Feb 24, 2014

Form 483

14 observations

Jul 13, 2011

FDA inspection

NAI classification

Apr 27, 2011

FDA inspection

VAI classification

Apr 27, 2011

Form 483

1 observation

Jun 14, 2010

FDA inspection

VAI classification

Jun 14, 2010

Form 483

14 observations

Combined chronology of the public records shown on this page. FDA coverage varies by dataset and year.

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.

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Source: FDA public data · status as of 2026-08-22