Drug factory · FDA FEI 3004680543

Przedsiebiorstwo Farmaceutyczne Jelfa S.A.

ul. Wincentego Pola 21, Jelenia Gora, Poland

Problems found, fixed voluntarily at FDA's last inspection, Mar 21, 2025.

Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.

7 drug inspections on record since 2010: 2 with no problems, 4 with problems fixed voluntarily, 1 with FDA action.

What it does, for whom

Drug	Role	For	NDC
Methylergonovine	Makes it	Breckenridge Pharmaceutical, Inc., Pharmacist Pharmaceutical, LLC	51991-144, 63704-004

FDA inspection history

Ended	Result	Program	Problems noted
Mar 21, 2025	Problems found, fixed voluntarily	Drug Quality Assurance	—
Nov 25, 2022	Problems found, fixed voluntarily	Drug Quality Assurance	—
Mar 13, 2018	No problems found	Drug Quality Assurance	—
Sep 22, 2016	Problems found, fixed voluntarily	Drug Quality Assurance	—
Jun 30, 2014	No problems found	Drug Quality Assurance	—
May 15, 2012	Problems found, fixed voluntarily	Drug Quality Assurance	10
Oct 22, 2010	Serious problems, FDA action	Drug Quality Assurance	—

What inspectors wrote down

From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.

May 15, 2012 inspection

Procedures for sterile drug products 21 CFR 211.113(b)
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established.
Written program not followed 21 CFR 211.166(a)
The written stability testing program is not followed.
Laboratory Test Method Verification 21 CFR 211.194(a)(2)
Verification of the suitability of the testing methods is deficient in that they are not performed under actual conditions of use and documented on the laboratory records.
Complete Test Data 21 CFR 211.194(a)(4)
Laboratory records are deficient in that they do not include a complete record of all data obtained during testing.
Calculations performed are in the records 21 CFR 211.194(a)(5)
Laboratory records do not include a record of all calculations performed in connection with the test.
Test method modification records not maintained 21 CFR 211.194(b)
Complete records are not maintained of any modification of an established method employed in testing.
Adequate lab facilities not available 21 CFR 211.22(b)
Adequate lab facilities for testing and approval or rejection of components and drug products are not available to the quality control unit.
Procedures not in writing, fully followed 21 CFR 211.22(d)
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
Equipment Design, Size and Location 21 CFR 211.63
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use.
Written procedures fail to include 21 CFR 211.67(b)
Written procedures for cleaning and maintenance fail to include description in sufficient detail of methods, equipment and materials used.

Registered with FDA for: manufacture.