Drug factory · FDA FEI 3003855180

Tedor Pharma Inc.

400 Highland Corporate Drive, Cumberland, RI, United States

Problems found, fixed voluntarily at FDA's last inspection, Jun 5, 2025.

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

5 drug inspections on record since 2011: 0 with no problems, 5 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

Drug	Role	For	NDC
Methylphenidate	Makes it and tests it	Rising Pharma Holdings, Inc.	64980-221, 64980-222, 64980-223

Ended	Result	Program	Problems noted
Jun 5, 2025	Problems found, fixed voluntarily	Drug Quality Assurance	2
Jan 31, 2019	Problems found, fixed voluntarily	Drug Quality Assurance	—
Apr 20, 2017	Problems found, fixed voluntarily	Drug Quality Assurance	4
Oct 29, 2013	Problems found, fixed voluntarily	Drug Quality Assurance	—
Sep 9, 2011	Problems found, fixed voluntarily	Drug Quality Assurance	—

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

Scientifically sound laboratory controls 21 CFR 211.160(b)
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications designed to assure that components and drug products conform to appropriate standards of identity, strength, quality and purity.
Training--operations, GMPs, written procedures 21 CFR 211.25(a)
Employees are not given training in the particular operations they perform as part of their function.

Procedures for non-sterile drug products 21 CFR 211.113(a)
Procedures designed to prevent objectionable microorganisms in drug products not required to be sterile are not followed.
Items to cover on annual reviews 21 CFR 211.180(e)(2)
Written procedures are not followed for evaluations done at least annually and including provisions for a review of complaints, recalls, returned or salvaged drug products and investigations conducted for each drug product.
Manufacturing Instructions and Specifications 21 CFR 211.186(b)(9)
The master production and control records are deficient in that they do not include complete manufacturing, control and specifications.
Extent of discrepancy, failure investigations 21 CFR 211.192
Investigations of a failure of a batch or any of its components to meet any of its specifications did not extend to other batches of the same drug product.

Registered with FDA for: analysis; manufacture.